N/A TIN3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403043796), received between Dec 28, 2020 and Feb 17, 2022 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2021Open, Classified

   Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

   Z-2249-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2022Break; Break

  IT WAS REPORTED THAT NEEDLE BROKE IN HALF WHILE IN PATIENT'S BONE. VERBATIM: BONE MARROW NEEDLE BROKE IN HALF AT THE HANDLE SIDE WHILE IN PATIENT¿S BONE. THE PATIENT WAS SEDATED FOR THE PROCEDURE, NO ADDITIONAL BLEEDING. TEAM HAD TO USE NEEDLE EXTRACTOR TO REMOVE. PATIENT REQUIRED AN ADDITIONAL BONE MARROW FOR SAMPLES. ADDITIONAL STRESS ON PATIENT AND FAMILY AS THEY WAIT BONE MARROW RESULTS ON TOP OF THE OCCURRENCE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13551176 ↗
• InjuryFeb 15, 2022Break; Break

  IT WAS REPORTED THAT NEEDLE BREAK IN HALF YESTERDAY, AND THE NEEDLE WAS STUCK IN THE PATIENT. EMAIL VERBATIM: WE HAD A BONE MARROW ASPIRATION NEEDLE BREAK IN HALF YESTERDAY, AND THE NEEDLE WAS STUCK IN THE PATIENT. SINCE THE HANDLE BROKE OFF, THEY HAD TO USE A NEEDLE DRIVER TO REMOVE IT. (THERE WAS A PORTION OF THE NEEDLE STICKING OUT THEY COULD PULL). THIS IS A HUGE ISSUE THAT WE HAVE NEVER SEEN BEFORE. IS THERE A CONTACT AT CAREFUSION WE CAN REPORT THIS TO? I HAVE FILLED OUT THE SOR. THE PRODUCT IS BONE MARROW ASPIRATION/INTRAOSSEOUS INFUSION NEEDLE REF TIN3015 15G X 79MM. WE HAD A BONE MARROW NEEDLE SNAP DURING INSERTION REQUIRING EXTRACTION WITH A NEEDLE DRIVER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13535790 ↗
• InjuryJan 4, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT "NEEDLE PUNCTURING THROUGH AND POKING STAFF" . NEEDLE PUNCTURING THROUGH AND POKING STAFF. WHAT WAS THE NEEDLE PUNCTURING THROUGH? NEEDLE PUNCTURED THROUGH THE SURGICAL KITS OUTER LAYERS ¿ I.E., BACK TABLE COVER. DID THE STAFF HAVE ANY MEDICAL INTERVENTION? NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13154674 ↗
• InjuryJan 4, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT "NEEDLE PUNCTURING THROUGH AND POKING STAFF." NEEDLE PUNCTURING THROUGH AND POKING STAFF. WHAT WAS THE NEEDLE PUNCTURING THROUGH? NEEDLE PUNCTURED THROUGH THE SURGICAL KITS OUTER LAYERS ¿ I.E., BACK TABLE COVER. DID THE STAFF HAVE ANY MEDICAL INTERVENTION? NO. IF SAMPLE IS AVAILABLE, PLEASE PROVIDE ADDRESS RETURNING FROM (B)(6).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13153781 ↗
• MalfunctionDec 3, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT NEEDLES ARE NOT COVERED IN THE PACKAGING. VERBATIM: NEEDLES ARE NOT COVERED IN PACKAGING CAN PUNCTURE SOMEONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925781 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  PLEASE FIND ATTACHED THIRD PRODUCT COMPLAINT REGARDING TIN3015 JAMSHIDI ILLINOIS ASPIRATION NEEDLE 15G. PREVIOUS COMPLAINTS WERE LOGGED UNDER REF. (B)(4) AND REF. (B)(4). AS I SAID THIS IS THE THIRD PRODUCT COMPLAINT, RECEIVED FROM THE SAME CUSTOMER, RELATING TO THE SAME PRODUCT. WE ALREADY HAVE A BOX AWAITING TNT COLLECTION TOMORROW. COULD THIS BE PLEASE ESCALATED AS IT LOOKS LIKE EVERY MONTH WE RECEIVE THE SAME COMPLAINT. COULD I ASK YOU TO CHECK YOUR RECORDS AND RETENTION SAMPLES AND ADVISE IF ANY OTHER COMPLAINT HAS BEEN RECORDED AND WHAT CORRECTIVE ACTIONS HAVE BEEN UNDERTAKEN PLEASE. WE NEED TO COMMUNICATE FINDINGS WITH OUR CUSTOMER, IT¿S BEEN TWO MONTHS SINCE WE LOGGED THE VERY FIRST COMPLAINT AND WE HAVEN'T HEARD OF ANY INVESTIGATION FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11294073 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  THE TIP OF THE NEEDLE BENT AS PER PREVIOUS COMPLAINT NO. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11292894 ↗
• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  THE TIP OF THE NEEDLE WAS BENT DURING BIOPSY. ACCORDING TO THE NURSE, THE TIP OF THE NEEDLE HAS BEEN LONGER THAN THE STEERING, WHICH MAY HAVE CAUSED THE NEEDLE TO BEND. THIS HAS OCCURRED APPROX. 20 TIMES HI, PLEASE SEE ANSWERS BELOW FROM DISTRIBUTOR: HI (B)(6), WE HAVE SUPPLIED THESE BATCH NUMBERS TO (B)(4): 1374720; (B)(4) IN (B)(6) 2020. 1372717; (B)(4) IN (B)(6) 2020. 1350086; (B)(4) IN (B)(6) 2020 AND (B)(4) IN (B)(6) 2020. PATIENT IMPACTED; YES, SAMPLE HAS BEEN UNSUCCESSFUL AND THEREFORE THE PROCEDURE HAS BEEN DONE ONCE MORE. NO SERIOUS INJURY. NO ERRONEOUS RESULTS. NO ADDITIONAL MEDICAL INTERVENTION. NO OTHER SAFETY ISSUES. ACCORDING TO MY EXPERIENCE IT SEEMS THAT MANDRIN IS TOO SHORT COMPARED TO NEEDLE, MANUFACTURING FAILURE. ACCORDING TO CUSTOMER INFORMATION, TOTAL NUMBER OF AFFECTED NEEDLES IS (B)(4). PLEASE, SEND REPLACEMENT NEEDLES TO: (B)(4) (B)(6). BEST REGARDS, (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11174735 ↗
• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  THE TIP OF THE NEEDLE WAS BENT DURING BIOPSY. ACCORDING TO THE NURSE, THE TIP OF THE NEEDLE HAS BEEN LONGER THAN THE STEERING, WHICH MAY HAVE CAUSED THE NEEDLE TO BEND. THIS HAS OCCURRED APPROX. 20 TIMES. PLEASE SEE ANSWERS BELOW FROM DISTRIBUTOR: HI (B)(6), WE HAVE SUPPLIED THESE BATCH NUMBERS TO KUOPIO: 1374720; 60 EA IN (B)(6) 2020. 1372717; 50 EA IN (B)(6) 2020. 1350086; 50 EA IN (B)(6) 2020 AND 30 EA IN (B)(6) 2020. PATIENT IMPACTED; YES, SAMPLE HAS BEEN UNSUCCESSFUL AND THEREFORE THE PROCEDURE HAS BEEN DONE ONCE MORE. NO SERIUS INJURY. NO ERRONEOUS RESULTS. NO ADDITIONAL MEDICAL INTERVENTION. NO OTHER SAFETY ISSUES. ACCORDING TO MY EXPERIENCE IT SEEMS THAT MANDRINE IS TOO SHORT COMPARED TO NEEDLE, MANUFACTURING FAILURE. ACCORDING TO CUSTOMER INFORMATION, TOTAL NUMBER OF AFFECTED NEEDLES IS 20 EA. PLEASE, SEND REPLACEMENT NEEDLES TO: PHARMANOVA OY; LINNANKOSKENKATU 32; FI-06100 PORVOO; FINLAND. BEST REGARDS, (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11174422 ↗
• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  THE TIP OF THE NEEDLE WAS BENT DURING BIOPSY. ACCORDING TO THE NURSE, THE TIP OF THE NEEDLE HAS BEEN LONGER THAN THE STEERING, WHICH MAY HAVE CAUSED THE NEEDLE TO BEND. THIS HAS OCCURRED APPROX. 20 TIMES HI, PLEASE SEE ANSWERS BELOW FROM DISTRIBUTOR: HI LINA, WE HAVE SUPPLIED THESE BATCH NUMBERS TO KUOPIO: 1374720; 60 EA IN (B)(6) 2020 1372717; 50 EA IN (B)(6) 2020 1350086; 50 EA IN (B)(6) 2020 AND 30 EA IN (B)(6) 2020 PATIENT IMPACTED; YES, SAMPLE HAS BEEN UNSUCCESSFUL AND THEREFORE THE PROCEDURE HAS BEEN DONE ONCE MORE. NO SERIUS INJURY NO ERRONEOUS RESULTS NO ADDITIONAL MEDICAL INTERVENTION NO OTHER SAFETY ISSUES ACCORDING TO MY EXPERIENCE IT SEEMS THAT MANDRINE IS TOO SHORT COMPARED TO NEEDLE, MANUFACTURING FAILURE. ACCORDING TO CUSTOMER INFORMATION, TOTAL NUMBER OF AFFECTED NEEDLES IS 20 EA. PLEASE, SEND REPLACEMENT NEEDLES TO: PHARMANOVA OY LINNANKOSKENKATU 32 FI-06100 PORVOO FINLAND. BEST REGARDS, AARNO TAMMELA PHARMANOVA OY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11174390 ↗
• MalfunctionDec 28, 2020Material Twisted/Bent; Material Twisted/Bent

  HI, I HAVE JUST HAD A COMPLAINT REPORTED TO ME THAT SIX BONE BIOPSY NEEDLES HAVE FAILED IN (B)(6). (B)(4) JAMSHIDI NEEDLE LOT TBC. (B)(6). MORE DETAILS TO FOLLOW IN THE MORNING. MORE DETAILS RECEIVED: FURTHER TO OUR CONVERSATION, WE HAVE HAD A PRODUCT COMPLAINT TODAY FROM OUR BIGGEST USER OF CODE (B)(4), LOT 0001374321. THE CUSTOMER HAS RECEIVED 20 BOXES OF THIS BATCH SINCE THE BEGINNING OF OCTOBER AND THEY ESTIMATE THEY HAVE APPROX. 9 BOXES REMAINING. ISKUS HAVE NO STOCK OF THIS NEEDLE AND ARE AWAITING A SHIPMENT THIS FRIDAY OF SAME. THE USER WAS CARRYING OUT A BIOPSY AND THEY STATED ¿THE TIP OF THE NEEDLE BENT AND SO WE WERE UNABLE TO PROPERLY OBTAIN A SAMPLE FROM THE PATIENT. IT SEEMS TO RENDER THE NEEDLE BLUNT SO THE NEEDLE CANNOT GET THROUGH THE BONE AND OBTAIN AN ASPIRATE SAMPLE. THIS HAPPENED TO THREE NEEDLES DURING THE PROCEDURE.¿ HAVING ENQUIRED WITH THE USER AND ANOTHER DOCTOR WHO USES THE NEEDLE, IT APPEARS THERE HAVE BEEN 6 NEEDLES WHERE THIS HAS HAPPENED OVER THE PAST MONTH. THE CUSTOMER WOULD LIKE US TO REMOVE THE REMAINING STOCK AND REPLACE WITH A DIFFERENT BATCH, AS THEY DON¿T WANT TO HAVE THIS ISSUE HAPPEN AGAIN WITH ANOTHER PATIENT. WE WILL SEND ON OUR OFFICIAL CO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11082788 ↗